Pursuant to section
801(a)(2)(A) of title 5, United States Code, this is our report on a major rule
promulgated by the Department of Health and Human Services, Food and Drug
Administration (FDA), entitled "Use of Ozone-Depleting Substances; Removal of
Essential-Use Designation (Flunisolide, etc.)" (RIN: 0910-AF92). We received the rule on April 16, 2010. It was published in the Federal Register as a final rule on April 14, 2010. 75 Fed. Reg. 19,213. The rule has stated effective dates ranging
from June 14, 2010, to December 31, 2013.

The final rule amends FDA's regulations on the use of ozone-depleting
substances (ODSs) in self-pressurized containers to remove the essential-use
designations for flunisolide, triamcinolone, metaproterenol, pirbuterol,
albuterol and ipratropium in combination, cromolyn, and nedocromil used in oral
pressurized metered-dose inhalers (MDIs).
FDA has concluded that there are no substantial technical barriers to
formulating these products so that they do not release ODSs, and therefore they
will no longer be essential uses of ODSs as of the effective dates of this
rule. MDIs for these active moieties
containing an ODS may not be marketed after the relevant effective date. With this rule, FDA removes the last remaining
essential-use designations for chlorofluorocarbons (CFCs) used in MDIs for the
treatment of asthma and chronic obstructive pulmonary disease.

Enclosed is our assessment of the FDA's compliance with
the procedural steps required by section 801(a)(1)(B)(i) through (iv) of title
5 with respect to the rule. Our review
of the procedural steps taken indicates that FDA complied with the applicable
requirements.

If you have any questions about this report or wish to
contact GAO officials responsible for the evaluation work relating to the
subject matter of the rule, please contact Shirley A. Jones, Assistant General
Counsel, at (202) 512-8156.

REPORT UNDER 5 U.S.C. sect. 801(a)(2)(A) ON A MAJOR
RULE
ISSUED BY THE
DEPARTMENT OF HEALTH AND HUMAN SERVICES,
FOOD AND DRUG ADMINISTRATION
ENTITLED
"USE OF OZONE-DEPLETING SUBSTANCES;
REMOVAL OF ESSENTIAL-USE DESIGNATION
(FLUNISOLIDE, ETC.)"
(RIN: 0910-AF92)

(i) Cost-benefit analysis

The
Food and Drug Administration (FDA) analyzed the costs and benefits of this final
rule. According to FDA, the benefits of
this rule include environmental and public health improvements from protecting
stratospheric ozone by reducing chlorofluorocarbons (CFCs) emissions. FDA also expect the benefits to include
expectations of increased returns on investments in environmentally friendly
technology and continued international cooperation to comply with the spirit of
the Montreal Protocol, thereby potentially reducing future emissions of ozone-depleting
substances (ODSs) throughout the world.

FDA
determined that the costs of the final rule would include increased spending
for needed medicines used to treat asthma and Chronic Obstructive Pulmonary
Disease (COPD). FDA determined that the
social costs of the final rule include the health benefits lost through
decreased use of medicines that may result from increased prices. FDA was unable to quantify the economic costs
of reducing the variety of marketed products from which consumers, and their
doctors, can choose. FDA estimated that,
depending on whether asthma and COPD patients use the most or least expensive
of alternatives, private, third-party, and public expenditures on inhaled
medicines would increase by roughly $90 million to $280 million per year.

FDA determined that this final rule includes a federal
mandate that may result in the expenditure by state, local, or tribal
governments, in the aggregate, or by the private sector, of $100 million ($133
million adjusted for inflation at 2008 levels) or more in any one year. FDA stated that it examined the impacts of
this rule under the Act.

(iv) Other relevant information or requirements under
acts and executive orders

Administrative Procedure Act, 5 U.S.C. sections 551 etseq.

On June 11, 2007, FDA published a proposed rule. 72 Fed. Reg. 32,030. FDA received over 4,000 comments in response
to the proposed rule and held an open public meeting on the rule on August 2,
2007. Comments were submitted by
consumers, health care providers, patient advocacy groups, manufacturers, a congressional
caucus, and industry organizations. FDA
responded to these comments in the final rule.

Paperwork Reduction Act, 44 U.S.C. sections 3501-3520

FDA determined that this final rule contains no
information collection requirements under the Act.

Statutory authorization for the rule

FDA promulgated this final rule under the authority of
sections 402 and 409 of title 15; sections 321, 331, 335, 342, 343, 346a, 348,
351, 352, 355, 360b, 361, 362, 371, 372, and 374 of title 21, and sections
7671–7671q of title 42, United States Code.

FDA concluded that this final rule will not have a
significant impact on the human environment and that an environmental impact
statement is not required.

Executive Order No. 12,866 (Regulatory Planning and
Review)

FDA determined that this final rule is an economically
significant rule under the Order. The
Office of Management and Budget reviewed this rule.

Executive Order No. 13,132 (Federalism)

FDA determined that this final rule does not contain
policies that have substantial direct effects on the states, on the
relationship between the national governments and the states, or on the
distribution of power and responsibilities among the various levels of
government.